Broncochem
DEXTROMETHORPHAN HBr-GUAIFENESIN · Syrup · Oral
Active ingredient
Active Ingredients Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl
Purpose
Purpose Analgesic Antihistaminic Antotussive Expectorant Decongestant
Uses
Indications & Use Bronchial congestion Irritation of the respiratory passages Nasal congestion Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive Antitussive Temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis
Warnings
Warnings Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlem (mucus). Likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor. A persistent cough may be a sing of a serious condition. Stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache. As with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing Pseudoephedrine HCl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.
Keep out of reach of children
Keep Out Of the Reach Of children In case of accidental overdose, seek professional assistancve or contact a poison control center inmediately
Directions
Dosage and Administration Do not exceed 6 doses in a 24 hour period Adults and chuildren 12 years and over: (10mL or cc) using metered dosage spoon every 4 hours. Children 6 years up to 12 years: (5mL or cc) using metered dosage spoon every 4 hours
Inactive ingredients
Iactive Ingredient Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.
Label text from the FDA structured product label by LABORATORIO MAGNACHEM INTERNATIONAL SRL (revised Mar 23, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dextromethorphan Hydrobromide in 10 products
- Acetaminophen in 7 products
- Guaifenesin in 7 products
- Phenylephrine Hydrochloride in 7 products
- Chlorpheniramine Maleate in 6 products
- Pyrilamine Maleate in 2 products
Broncochem NDC products (14)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 65131-011 | Acetaminophen 325 mg/10mL; Dextromethorphan Hydrobromide 20 mg/10mL; Guaifenesin 400 mg/10mL; Phenylephrine… Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH DRUG |
| 65131-035 | Dextromethorphan Hydrobromide 15 mg/5mL; Pyrilamine Maleate 6 mg/5mL Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH DRUG |
| 65131-097 | Acetaminophen 500 mg/13g; Chlorpheniramine Maleate 4 mg/13g Granule, For Solution | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH DRUG |
| 65131-100 | Dextromethorphan Hydrobromide 20 mg/10mL; Guaifenesin 400 mg/10mL Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH DRUG |
| 65131-101 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 20 mg/1; Phenylephrine Hydrochloride 10 mg/1; Chlorpheniramine… Tablet, Coated | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH DRUG |
| 65131-109 | Acetaminophen 325 mg/10mL; Phenylephrine Hydrochloride 10 mg/10mL; Guaifenesin 200 mg/10mL Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH DRUG |
| 65131-110 | Dextromethorphan Hydrobromide 30 mg/5mL; Pyrilamine Maleate 50 mg/5mL Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH DRUG |
| 65131-111 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 30 mg/1; Phenylephrine Hydrochloride 5 mg/1; Chlorpheniramine… Tablet, Coated | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH DRUG |
| 65131-180 | Dextromethorphan Hydrobromide 10 mg/15mL; Guaifenesin 100 mg/15mL Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH DRUG |
| 65131-418 | Chlorpheniramine Maleate 2 mg/10mL; Dextromethorphan Hydrobromide 10 mg/10mL Syrup | LABORATORIO MAGANCEHM INTERNATIONAL SRL | OTC MONOGRAPH FINAL |
| 65131-054 | Acetaminophen 325 mg/10mL; Phenylephrine Hydrochloride 5 mg/10mL; Guaifenesin 200 mg/10mL Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH FINAL |
| 65131-091 | Dextromethorphan Hydrobromide 30 mg/10mL; Guaifenesin 200 mg/10mL Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH FINAL |
| 65131-098 | Chlorpheniramine Maleate 4 mg/10mL; Phenylephrine Hydrochloride 10 mg/10mL Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH FINAL |
| 65131-116 | Acetaminophen 250 mg/10mL; Chlorpheniramine Maleate 4 mg/10mL; Dextromethorphan Hydrobromide 13.33 mg/10mL; Guaifenesin… Syrup | LABORATORIO MAGNACHEM INTERNATIONAL SRL | OTC MONOGRAPH NOT FINAL |
Broncochem recalls
- D-0387-2024 Mar 20, 2024 · Class II · Ongoing
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Frequently asked questions
What is Broncochem used for?
Indications & Use Bronchial congestion Irritation of the respiratory passages Nasal congestion Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive Antitussive Temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis
Who makes Broncochem?
Broncochem is listed by 2 labelers in the FDA NDC directory, including LABORATORIO MAGNACHEM INTERNATIONAL SRL, LABORATORIO MAGANCEHM INTERNATIONAL SRL.
Has Broncochem been recalled?
The FDA enforcement database lists 1 recall for Broncochem, most recently D-0387-2024 (class ii): Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or…